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» Vanilla is the cured, full-grown, unripe fruit of Vanilla planifolia Jacks., often known in commerce as Mexican, Bourbon, or Madagascar vanilla, or of Vanilla tahitensis J.W. Moore, known in commerce as Tahitian vanilla (Fam. Orchidaceae). Vanilla yields not less than 12.0 percent of anhydrous, diluted, alcohol-soluble extractive.
Packaging and storage— Preserve in tight containers, and store in a cold place.
Labeling— The label states the Latin binomial and, following the official name, the part of the plant contained in the article. The commercial variety of Vanilla, whether Mexican, Bourbon, Madagascar, or Tahitian, is also stated on the label. The label states that Vanilla that has become brittle is not to be used.
Botanic characteristics—
Unground Vanilla— The linear, flattened capsule, from 12 to 35 cm in length and from 5 to 9 mm in width, has an apex terminating in a flat, circular scar and a gradually tapering base which is more or less curved or hooked, or in Tahitian vanilla, broad in the middle and tapering toward either end, the base closely resembling the summit. It is flexible and tough, nearly black, dusky brown to moderate brown externally, longitudinally wrinkled, moist, glossy, and occasionally has efflorescence of acicular or prismatic crystals of vanillin. Internally it is unilocular, with a brownish black pulp and numerous minute seeds. Occasional capsules are split near the summit into three parts.
Histology— The epidermis has a distinct cuticle and occasional stomata. The epidermal cells contain red to brown bodies and occasional prisms of calcium oxalate or crystals of vanillin. It has a collenchyma layer of one or two rows of cells, a thick sarcocarp composed of parenchyma and an interrupted circle of fibrovascular bundles, the latter leptocentric with a few vessels, and an outer circle of fibers with thin, strongly lignified walls and numerous transverse simple pits. The vessels with walls have slit-like pits or spiral thickenings; the parenchyma cells are usually thin-walled and deeply undulate, some thick-walled with oblique, slit-like pits or broad spiral bands, and contain occasional bundles of acicular crystals of calcium oxalate, up to 400 µm in length, or a thin protoplasmic layer enclosing numerous oil globules. It has an endocarp composed of placental and interplacental regions; the placental region consists of six bifid placentas extending into the cavity of the fruit and bears irregularly trianguloid, black to reddish, flattened seeds, up to about 250 µm in diameter, having a deeply reticulate seed coat; the interplacental regions show long, nearly straight hairs more or less matted together by their gummy, resinous secretion.
Powdered Vanilla— It is dusky brown to nearly black. The principal elements of identification are fragments of parenchyma of the sarcocarp with long, oblique, slit-like walls or broad spiral bands, calcium oxalate crystals of acicular outline and up to 400 µm in length, and monoclinic prisms up to 35 µm in length. It has numerous unicellular, nearly straight, glandular hairs, fragments of the seed coat with polygonal stone cells, and slender crystals of vanillin.
Test for vanillin— Place a few of the crystals, occurring as an efflorescence on the fruit, on a microslide or watch glass, and add 1 drop of phloroglucinol TS and 1 drop of hydrochloric acid: the solution immediately acquires a red color.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Place 2 g of Vanilla, finely cut or coarsely powdered and accurately weighed, in a suitable flask, add 70 mL of Diluted Alcohol, shake by mechanical means for 2 hours or for 8 hours at 30-minute intervals, and allow to stand overnight. Decant the liquid into a filter, and wash the flask and residue with small portions of Diluted Alcohol, passing the washings through the filter until the filtrate measures 100.0 mL. Mix the filtrate well, evaporate a 50.0-mL portion in a suitable tared container on a steam bath to dryness, and dry the residue at 105 for 4 hours. The weight obtained represents the yield of anhydrous, diluted, alcohol-soluble extractive from one-half of the portion of Vanilla taken.
Auxiliary Information— Staff Liaison : Claudia C. Okeke, Ph.D., Associate Director
Expert Committee : (CRX05) Compounding Pharmacy05
USP29–NF24 Page 3454
Pharmacopeial Forum : Volume No. 27(4) Page 2804
Phone Number : 1-301-816-8243